Using a Balance in the Pharmaceutical Laboratory: Implications of Recent Revisions to USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance
Date: Tuesday February 25, 2014
Time: 1:00 PM ET | 10:00 AM PT
Duration: 2 hours
Goals and Objectives
This course is designed to inform participants about the recent changes to the USP General Chapters related to Balances and Weighing on an Analytical Balance, and to discuss the implications. The requirements for repeatability have changed, and the need to determine the minimum acceptable weight (and use it properly) is more apparent. There have been major changes to USP <1251>, which now focuses on balance qualification and operation. The course will provide practical information regarding the meaning and intent of the chapters, regulatory expectations and tips for implementation.
Upon completion of this course the learner should be able to:
Be informed of the significant changes to USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance.
Understand the implications of the term ‘accurately weigh’ when used in the USP, and recognize that other uses may have different requirements.
Understand the requirements for repeatability and accuracy when using a balance.
Understand the requirements for qualification of an analytical balance, including IQ, OQ, PQ and balance checks.
Be familiar with the concept of ‘minimum weight’ for a balance.
Understand the types of weighing which may be performed, and the impacts of receivers and some problem samples.
Background: Rationale for Revisions
USP <41> Balances
Repeatability limits changed
Weight classes removed
Requirements for repeatability and accuracy
USP <1251> Weighing on an Analytical Balance
Types of weighing
Who Should Attend
Chemists, Metrologists, Managers and Regulatory Affairs personnel in Pharmaceutical Innovator, Generic, Over-the Counter , Nutraceutical or Excipient companies, or Contract Research Organizations which support them, involved in weighing of drug substances, drug products, over-the-counter products, nutraceuticals or excipients.
Mr. Gregory P. Martin President
Complectors Consulting LLC
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. Mr. Martin is co-author (with Vivian A. Gray) of the series “Dissolution Concepts and Applications” which has appeared in Journal of Validation Technology and Journal of GXP Compliance. He can be contacted at firstname.lastname@example.org
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00 Group of 6 to 10 attendees per location: CAD $750.00 Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.